S5362 REF 943-906 943-906

GUDID 05700699439062

S5362 Hypochlorit Solution for protein Removal and decontamination 100mL for BPH5, ABL5/50/5XX, EML10X ABL8XX

Radiometer Medical ApS

Wash/cleaning solution IVD, automated/semi-automated system
Primary Device ID05700699439062
NIH Device Record Key57716c29-4fd3-46e4-ae75-5045f6a96210
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5362 REF 943-906
Version Model Number943-906
Catalog Number943-906
Company DUNS308667539
Company NameRadiometer Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+45999999999
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699439062 [Primary]

FDA Product Code

JFPELECTRODE, ION SPECIFIC, CALCIUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

Devices Manufactured by Radiometer Medical ApS

55700699428764 - CLINITUBES D941G-NA-240-85X102023-04-20 D941G-NA-240-85x10 CLINITUBES 10 vials of 75 units, Multipack
55700699044391 - CAPILLARY CAPS, RED 160pcs.2022-12-13 Capillary Caps, Red bag of 160 units
55700699044537 - CAPILLARY CAPS, green 110pcs.2022-12-13 Capillary Caps, Green bag of 110 units
55700699056615 - CLINITUBES D956G-70-35*12022-12-13 D956G-70-35x1 CLINITUBES 1 vial of 75 units. 35 µL. Multipack w. accessories
55700699060223 - ABL77 CAPILLARY ADAPTERS2022-12-13 Capillary adaptor vented, 100 pcs. for ABL77
05700699339393 - AQURE NT Premium2022-12-13 AQURE NT Premium
05700699339409 - AQURE NT Plus2022-12-13 AQURE NT Plus
55700699428696 - CLINITUBES D957G-70-35X52022-12-13 D957G-70-35x5 CLINITUBES 5 vials of 75 units. 35 µL. Multipack w. accessories

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